BEUDAMED
    35 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

    FDA Recall
    Open, Classified ·Product code LXH·February 4, 2019

    GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 18, 2024

    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code JAK·January 19, 2019

    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KPS·December 10, 2020

    SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

    FDA Recall
    Open, Classified ·Covidien LLC·Product code BZT·April 23, 2026

    Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

    FDA Recall
    Open, Classified ·Covidien LLC·Product code BZT·April 23, 2026

    Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

    FDA Recall
    Open, Classified ·Covidien LLC·Product code BZT·April 23, 2026

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code FZT·December 3, 2024

    SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024